BioPlex 2200
U.S. Only IFU, Manual & CDs, BioPlex 2200 25-OH Vitamin D IFU SW4.2_v3
1manufacturer
6catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | MRG |
| Device type | System, Test, Vitamin D |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1825 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-12 |
| Record revised | 2021-07-29 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SW4.2 V3 | 1 Each | In distribution |
| 4.2_v3 | 1 Each | In distribution |
| 4.3_v5 | 1 Each | In distribution |
| 4.3_v5 | 1 Each | In distribution |
| SW4.2V3 | 1 Each | In distribution |
| 6653750 | 200 Tests | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 3 |
| Maglumi 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 3 |
| Architect | Abbott Medical | 3 |
| Atellica™ IM VitD | Siemens Healthcare Diagnostics Inc | 2 |
| 1,25 Dihydroxy Vitamin D RIA | Immunodiagnostic Systems Ltd. | 2 |
| Maglumi 2000 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Ireland | 2 |
| Elecsys Vitamin D total II | Roche Diagnostics Gmbh | 2 |
| IDS-iSYS 25 VitDS | Immunodiagnostic Systems Ltd. | 2 |
| Elecsys Vitamin D total III | Roche Diagnostics Gmbh | 2 |
| Advia Centaur® VitD | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 50. All products under System, Test, Vitamin D
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180577 | 2018-06-22 |
| K141114 | 2015-01-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.